Carpal Tunnel, Carpal Tunnel Syndrome, Carpal Tunnel Syndrome Bilateral, Carpal Tunnel Syndrome Left, Carpal Tunnel Syndrome Right
Conditions
Brief summary
This study will complete a randomized controlled trial to quantitatively measure patient decisional conflict (Decisional Conflict Scale) in 150 patients treated for CTS with the tool compared to 150 patients treated with standard care. The investigators hypothesize patients treated for CTS will have lower decisional conflict with the tool.
Detailed description
The investigators will measure decisional conflict in 150 new patients being evaluated for CTS with the tool compared to 150 patients being evaluated for CTS with standard care. Those patients randomized to receiving the tool will use it to identify their preferences for certain attributes of care. Patients will then be presented with their preference data and the surgeon will have a discussion with the patient regarding CTS. Surgeons will have their standard discussion with the patients randomized to the standard care group (no tool). The tool will be operationalized on a Health Insurance Portability and Accountability Act compliant data platform, such as Qualtrics, and no identifiable data will be collected. De-identified data will be shared from study cites with our team at Stanford. This data will be backed up on a computer encrypted by Stanford.
Interventions
A preference elicitation tool for carpal tunnel syndrome
Sponsors
Duke University
Brown University
University of Texas at Austin
Mayo Clinic
Harvard University
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
No masking will occur
Intervention model description
Participants are randomly assigned to either the intervention or control group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* New patient * English fluency and literacy * Able to take informed consent * clinical diagnosis of carpal tunnel syndrome
Exclusion criteria
* Prior diagnostic testing for carpal tunnel (nerve test, ultrasound) * Prior carpal tunnel release * Diagnosis of C5/6 radiculopathy (double crush) * Peripheral neuropathy (ex: diabetic) * Worker Compensation/EMG Required * Symptoms of Cubital tunnel syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decisional Conflict Scale | Immediately after using tool (up to 5 minutes to complete survey) | The Decisional Conflict Scale measures uncertainty in choosing options; modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making; and effective decision making such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice. The survey consists of 16 statements with 5 response categories. Scoring: total scale-0 (no decisional conflict) to 100 (extreme decisional conflict). Lower values indicate lower decisional conflict- i.e. a better outcome for use of the tool. Calculation: Summed, divided by # of items, multiplied by 25 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control None- normal care | 19 |
| Intervention Patients use a preference elicitation tool to determine their preferences for diagnosis and treatment of CTS | 30 |
| Total | 49 |
Baseline characteristics
| Characteristic | Control | Intervention | Total |
|---|---|---|---|
| Age, Continuous | 57.3 years STANDARD_DEVIATION 17.9 | 54.6 years STANDARD_DEVIATION 18.5 | 55.5 years STANDARD_DEVIATION 18 |
| CTS-6 | 18.2 units on a scale STANDARD_DEVIATION 5.9 | 18.1 units on a scale STANDARD_DEVIATION 3.8 | 18.2 units on a scale STANDARD_DEVIATION 4.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) White | 12 Participants | 18 Participants | 30 Participants |
| Region of Enrollment United States | 19 Participants | 30 Participants | 49 Participants |
| Sex: Female, Male Female | 10 Participants | 18 Participants | 28 Participants |
| Sex: Female, Male Male | 9 Participants | 12 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 30 |
| other Total, other adverse events | 0 / 19 | 0 / 30 |
| serious Total, serious adverse events | 0 / 19 | 0 / 30 |
Outcome results
Primary
Decisional Conflict Scale
The Decisional Conflict Scale measures uncertainty in choosing options; modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making; and effective decision making such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice. The survey consists of 16 statements with 5 response categories. Scoring: total scale-0 (no decisional conflict) to 100 (extreme decisional conflict). Lower values indicate lower decisional conflict- i.e. a better outcome for use of the tool. Calculation: Summed, divided by # of items, multiplied by 25
Time frame: Immediately after using tool (up to 5 minutes to complete survey)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Decisional Conflict Scale | 1.77 score on a scale | Standard Deviation 4.6 |
| Intervention | Decisional Conflict Scale | 4.41 score on a scale | Standard Deviation 10.3 |